Device for reversing the blood flow for an extracorporeal blood treatment device and method for determining the reversal of the blood flow during an extracorporeal blood treatment

ABSTRACT

The invention relates to a device for reversing the blood flow for an extracorporeal blood treatment device, comprising an extracorporeal blood circuit (I), which includes an arterial blood line ( 108 A) leading from a patient to a blood treatment unit ( 204 ) and a venous blood line ( 106 A) leading from the blood treatment unit to the patient. Furthermore, the invention relates to an extracorporeal blood treatment device with a device for reversing the blood flow, and to a method for determining the reversal of the blood flow during an extracorporeal blood treatment. The device for reversing the blood flow for an extracorporeal blood treatment device according to the invention comprises two valve bodies ( 102, 104 ) which are rotated relative to one another for reversing the blood flow. The device for reversing the blood flow according to the invention is characterized by a communication device ( 210 ) for receiving an electromagnetic high-frequency field from a read unit ( 270 ) of the extracorporeal blood treatment device and for generating at least one identifier characterizing the position of the valve bodies which can be read by the read device.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/123,290, filed on Apr. 8, 2011, which is a national phase applicationbased on PCT International Patent Application No. PCT/EP2009/007066,filed on Oct. 2, 2009, and German Patent Application No. 10 2008 050848.7, filed on Oct. 8, 2008, the entire contents of which areincorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates to a device for reversing blood flow, foran extra-corporeal blood treating apparatus which comprises anextra-corporeal blood circuit which has an arterial blood line outgoingfrom a patient which runs to a blood treating unit and a venous bloodline outgoing from the blood treating unit which runs to the patient. Aswell as this, the present invention also relates to an extra-corporealblood treating apparatus having a device for reversing blood flow and toa method of detecting the reversal of blood flow in extra-corporealblood treatment.

BACKGROUND

In an extra-corporeal blood treating apparatus, such as a hemodialysisapparatus for example, the blood to be treated flows, in anextra-corporeal blood circuit, through the blood chamber of a dialyzerwhich is divided by a semi-permeable membrane into the blood chamber anda dialysis-fluid chamber, while in a dialysis-fluid system dialysisfluid flows through the dialysis-fluid chamber of the dialyzer. Theextra-corporeal blood circuit has an arterial flexible line which runsto the blood chamber and a venous flexible line outgoing from the bloodchamber. The flexible lines of the extra-corporeal blood treatingapparatus are generally provided in the form of disposable itemsintended for once-only use. The known pieces of blood treating apparatushave a blood pump, which is usually arranged upstream of the bloodchamber of the dialyzer, to ensure that there is an adequate flow ofblood in the extra-corporeal blood circuit.

For highly efficient hemodialysis treatments, it is necessary for theblood to be cleansed from the patient to be fed to the extra-corporealblood circuit at sufficiently high pumping rates. What is used for hispurpose is preferably an operatively produced connection between arteryand vein. Because of the bypassing of the peripheral vascular system,which presents a high resistance to flow, relatively high blow flows areobtained in the fistula or shunt, and these will be referred to in whatfollows as access flows. The extra-corporeal blood circuit is preferablyconnected up by means of two needles, with blood being withdrawn throughthe needle directed into the artery and being returned again through theneedle directed into the vein after passing through the extra-corporealblood circuit.

For different reasons, stenoses which result in a fall in the accessflow may, in the course of time, form in the fistula or shunt. If theaccess flow is lower than the flow in the extra-corporeal blood circuit,this causes a drop in the cleansing performance because (venous) bloodwhich is now already cleansed mixes with uncleansed (arterial) blood.This process is referred to as access recirculation. As well as by thefall in the access flow, the process may also be encouraged to occur byunfavorable positioning of the arterial and venous needles relative toone another.

By regular measurement of the access flow, it is intended that stenoseswhich are formed will be detected at an early stage, to enable steps tobe taken to restore the access flow at an early point in time if theflow drops below a critical level.

Measurement of the access flow is possible by, for example, duplexsonography. This, however, calls for a trained physician and acost-intensive diagnostic unit. Also, this method cannot be used withvery adipose patients. What has become established as a standard methodof determining access flow is the Krivitski method (Kidney Int (July)48: 244-250 1995). In this, with the venous and arterial needles changedover, a bolus of saline solution is injected into the extra-corporealblood tubing system and detected in the arterial and venous blood tubinglines by means of ultrasonic sensors. This method calls for anadditional cost-intensive piece of equipment and for the manualadministration of saline.

From European Patent Publication EP 0 928 614 B1 is known a method ofdetermining access flow which does not call for any other measuringdevices apart from the dialysis device and which manages without themanual injection of an indicator solution. In this case, clearance isdetermined, with constant blood and dialysis flows, with the needles intheir normal arrangement and in a reversed arrangement in succession,and the access flow is determined from the two values for clearance.

For reversing the blood flow in the extra-corporeal blood circuit, thereis known from PCT Publication No. WO 2006/042016 A2 a device whichprevents a loss of blood which is possible when the needles are changedover, which reduces the risk of infection and simplifies operation. Alsoknown is operator prompting implemented on the dialysis unit to allow anaccess flow measurement to be made by using the known device for flowreversal.

To determine access flow, measurements of clearance are maderespectively before and after the reversal of blood flow in theextra-corporeal blood circuit. The operator prompting which isimplemented on the dialysis unit tell the user when the reversal of flowis to be carried out. It is a disadvantage, however, that it is notautomatically detected whether the reversal of flow has in fact takenplace. If, incorrectly, there has not been a reversal of flow, themeasurement may give too high a value for the access flow. This mayresult in problems at the vascular access not being realized, especiallyas the user will assume that he has made a correct measurement.

There is also the risk of the blood flow not being reversed back to itsoriginal direction after a measurement has been made with the blood flowreversed. Because of the increased access circulation which occurs whenflow is reversed, this will then lead to a reduced dialysis dose.

For the automatic determination of the dialysis dose by the dialyzingunit, it is necessary for the current clearance to be known at all timesduring the treatment. For this purpose measurements arc made atdifferent points in time. If there is a change in the parameters whichaffect clearance, and in particular in the blood and dialysate flows,between the measurements, interpolation is possible on the basis of themeasurements which have been made and the known treatment parameters(German Patent Publication No. DE 19928407). Because the reversal offlow affects clearance, an exact knowledge of the length of time forwhich flow is reversed and of the duration of the treatment with thenormal direction of flow is needed for determining the dialysis dose.

There is a technique which is known by the name radio frequencyidentification (RFID) which is in general use for the identification andlocation of articles. The articles are identified with the help ofelectromagnetic waves. An RFID system comprises a transponder which issituated on the article and a reader for reading the identity code ofthe transponder. The reader generates a short-range, high-frequencyelectromagnetic field by which, generally, not only can data betransmitted but the transponder can also be supplied with energy.

RFID transponders are known in different forms. All RFID transpondershave an aerial which is connected to a transceiver. As well as theaerial and transceiver, what are also provided are a non-erasable memoryand other circuits.

Known from Japanese Patent Application Publications JP 2233079 A2, JP24232671 A2 and JP 2002333079 A2 are valves which have an RFIDtransponder to enable it to be detected whether the valve is open orclosed. US Patent Application Publication No. 2007/0277824 A1 describesan apparatus intended for diagnostic purposes in which correctpositioning of an insert is monitored by means of an RFID transponder.

The object underlying the present invention is to provide a device forreversing blood flow for an extra-corporeal blood treating apparatus,which device, with a high degree of safety and reliability, allows thesafety of the extra-corporeal blood treatment to be increased and themeasurement of parameters of the blood treatment to be simplified.

As well as this, the object underlying the present invention is also tospecify a method of detecting the reversal of blood flow inextra-corporeal blood treatment which is easy to operate and can besafely and reliably applied.

A further object of the present invention is to provide a blood treatingapparatus which, easily and with great safety and reliability, enables areversal of flow to be made to enable parameters of the blood treatmentto be measured.

These objects are achieved in accordance with the present invention byvirtue of the features of the present invention set forth herein.

SUMMARY

The device according to the present invention for reversing blood flowfor an extra-corporeal blood treating apparatus has two valve-actionbodies which are rotatable relative to one another. One valve-actionbody has a first patient-side connection for a first patient-sideportion, formed by flexible tubing, of the blood line and a secondpatient-side connection for a second patient-side portion, formed byflexible tubing, of the blood line, while the second valve-action bodyhas a first apparatus-side connection for a first apparatus-sideportion, formed by flexible tubing, of the blood line and a secondapparatus-side connection for a second apparatus-side portion, formed byflexible tubing, of the blood line.

The two valve-action bodies can be rotated relative to one another, on acommon axis, between a first position which corresponds to normal bloodflow and a second position which corresponds to reversed blood flow inthe extra-corporeal blood circuit. In the first position, a connectionfor liquid is made between the first patient-side connection and thefirst apparatus-side connection on the one hand, and between the secondpatient-side connection and the second apparatus-side connection on theother hand, whereas in the second position, a connection for liquid ismade between the first patient-side connection and the secondapparatus-side connection on the one hand, and between the secondpatient-side connection and the first apparatus-side connection on theother hand.

The device according to the present invention is intended for once-onlyuse, the flexible-tubing lines, which are likewise intended foronce-only use, being able to be connected to the apparatus-side andpatient-side connections.

The device according to the present invention for reversing blood flowis distinguished by having a communications arrangement for receiving ahigh-frequency electromagnetic field from a reading arrangementbelonging to the extra-corporeal blood treating apparatus and forgenerating at least one code which is characteristic of the positions ofthe valve-action bodies and which can be read by the readingarrangement.

The communications arrangement according to the present invention of theblood treating apparatus allows the direction of flow to be identifiedwithout a connection having to be made between the blood treatingapparatus and the device for reversing blood flow. The device forreversing blood flow can be operated easily because it merely needs tobe introduced into the extra-corporeal blood circuit, without howeverhaving to be connected to the blood treating apparatus electrically.

In a first preferred embodiment of the present invention, provision ismade for the communications arrangement to have a first RFID transponderand a second RFID transponder. The first RFID transponder transmits afirst code which is characteristic of the first position of thevalve-action bodies in this case, and the second RFID transpondertransmits a code which is characteristic of the second position. It isthus possible for use to be made of the known RFID transponders whichare also called RFID tags. These are notable for being small in size andlow in cost. The existing code of the given RFID transponder allows thedirection of the blood flow to be clearly identified.

A first variant of the first embodiment of the present invention relieson only one of the two RFID transponders being active. This is achievedby screening off the other RFID transponder electrically. In thisembodiment, the first RFID transponder is arranged at a pointcharacteristic of the first position, preferably on the inside face ofthe first or second valve-action body, while the second RFID transponderis arranged at a point characteristic of the second position, preferablyon the inside face of the first or second valve-action body. The firstand/or second valve-action body is screened off electrically in such away that it is only the first RFID transponder for transmitting the codecharacteristic of the first position which can be read by the readingarrangement in the first position, whereas in the second position it isonly the second RFID transponder for transmitting the codecharacteristic of the second position which can be read by the readingarrangement. It is immaterial in this case whether the transponders arethen arranged on one or the other of the valve-action bodies. What iscrucial is that, as a result of the valve-action bodies being turned tothe two positions, one transponder is screened off electrically and theother transponder is not screened off electrically.

The electrical screening off of the transponders can be accomplished bymeans of suitable metallizing on the inside or outside face of the givenvalve. It is however also possible for the valve-action body to be madeof a material which is not permeable to the high-frequencyelectromagnetic field.

In a particularly preferred embodiment, the first and second RFIDtransponders are situated opposite one another on the inside face of thefirst valve-action body on an axis which lies perpendicular to the axisof rotation of the valve-action bodies, the inside face of the secondvalve-action body being metallized to screen off the RFID transpondersexcept for a cut-out portion which is situated opposite the first RFIDtransponder in the first position and opposite the second RFIDtransponder in the second position. Consequently, only the first RFIDtransponder is active in the first position while only the second RFIDtransponder is active in the second position. Simple but reliableidentification of the direction of flow is achieved in this way.

In the particularly preferred embodiment, it is not absolutely essentialfor that valve-action body which is situated opposite the valve-actionbody which is metallized except for a cut-out portion also to bemetallized to screen it off electrically. However, this valve-actionbody also may be metallized for better screening-off.

A second variant of the first embodiment does not make provision for thegiven RFID transponder to be screened off electrically but for theaerial of the given transponder to be disconnected from its transceiver.In the first position, it is only the transceiver of the first RFIDtransponder which is connected to an aerial whereas in the secondposition it is only the transceiver of the second RFID transponder whichis connected to an aerial. What is achieved in this way is that the codeof only one of the two RFID transponders can be read by the readingarrangement to identify the direction of flow.

The two RFID transponders may each have an aerial or may also have onecommon aerial. The two RFID transponders preferably have only one commonaerial which can be connected to the transceiver of the giventransponder or disconnected from the transceiver as a function of theposition of the valve-action bodies.

The common aerial, and the transceiver of the given transponder, areconnected by means of electrical connections which are formed in thevalve-action body. A permanent, first electrical connection ispreferably made between the aerial and the transceiver, with the secondelectrical connection to one of the two transceivers being made viacontacts on the valve-action bodies as a function of the position of thevalve-action bodies.

The RFID transponders are preferably passive transponders which obtaintheir energy from the high-frequency electromagnetic signal from thereading arrangement. A power supply unit is therefore not required forthe device for reversing flow which is intended for once-only use.Basically, use could however also be made of active RFID transponders.

An alternative embodiment of the device according to the presentinvention is distinguished by the fact only a single RFID transponder isused to identify the direction of flow, which once again is preferably apassive transponder.

In this embodiment, an arrangement which detects the first and secondpositions of the valve-action bodies is provided which co-operates withthe RFID transponder is such a way that two different codes can be readby the reading arrangement, one of which is characteristic of the firstposition of the valve-action bodies and of which the other code ischaracteristic of their other position.

The blood treating apparatus according to the present invention isdistinguished by having a reading arrangement which is so designed thatthe code of the communications arrangement which is characteristic ofthe first or second position can be read.

The blood treating apparatus according to the present invention, whichhas an arrangement for determining a parameter of the blood treatment onthe basis of a first and a second measurement of a characteristicvariable made respectively before and after a reversal of blood flow,preferably has an alarm unit which co-operates with the arrangement fordetermining a parameter of the blood treatment in such a way that thealarm unit gives an audio and/or visual alarm if, after the firstmeasurement and/or the second measurement, the reading arrangement hasnot received the codes which are respectively characteristic of thefirst and second positions. This ensures that the blood flow has in factbeen reversed for the measurement to be made and/or that the normalblood flow has been established again after the measurement. It isimmaterial in this case which are the parameters of the blood treatmentwhich are to be determined. The only thing that is crucial is that themeasurement calls for a reversal of blood flow. Clearance, for example,may be measured.

In practice, the problem arises that a plurality of pieces of bloodtreating apparatus are operated in positions closely adjacent to oneanother at a treatment center, which means that it has to be ensuredthat there is a clear correlation between the reading arrangement of thepiece of blood treating apparatus and the associated device forreversing flow. A preferred embodiment of the blood treating apparatusaccording to the present invention therefore has an arrangement forrecognizing the communications arrangement of the associated device forreversing blood flow. The arrangement for recognizing the communicationsarrangement has means which are so designed that a change between thecodes characteristics of the first and second positions within a presetinterval of time can be detected. Thus, by turning the valve-actionbodies of that device for reversing flow which is associated with theblood treating apparatus, the user is able to produce an identificationsignal which is recognized by the associated blood treating apparatus.

The device according to the present invention may be used not only forreversing the flow of blood in an extra-corporeal blood circuit of anextra-corporeal blood treating apparatus but also for reversing flow inother systems handling liquids. One example of a use of the deviceaccording to the present invention other than in an extra-corporealblood circuit is the reversal of flow to flush clean a filter in asystem handling liquids.

Various embodiments of the present invention will be explained in detailin what follows by reference to the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view showing an embodiment of device accordingto the present invention for reversing blood flow in the extra-corporealblood circuit.

FIG. 2 is a section through the device shown in FIG. 1 taken on lineII-II.

FIG. 3A is a highly simplified schematic view of the extra-corporealblood treating apparatus according to the present invention which hasthe device for reversing blood flow, with the blood flow not reversed.

FIG. 3B shows the extra-corporeal blood treating apparatus shown in FIG.3A, with the blood flow reversed.

FIG. 4A is a perspective view of the first valve-action body of a firstembodiment of the device according to the present invention forreversing flow,

FIG. 4B is a perspective view of the second valve-action body of thefirst embodiment of the device according to the present invention forreversing flow,

FIG. 5A is a perspective view of the first valve-action body of a secondembodiment of a device according to the present invention for reversingflow,

FIG. 5B is a perspective view of the second valve-action body of thesecond embodiment of the device according to the present invention forreversing flow,

FIG. 6A is a perspective view of the first valve-action body of afurther embodiment of a device according to the present invention forreversing flow,

FIG. 6B is a perspective view of the second valve-action body of thefurther embodiment of a device according to the present invention forreversing flow.

DETAILED DESCRIPTION

FIG. 1 is a perspective view showing the device according to the presentinvention for reversing flow which is intended for once-only use. Thedevice 100 for reversing flow comprises a first valve-action body 104which is at the bottom in FIG. 1 and a second valve-action body 102which is at the top in FIG. 1. FIG. 2 is a view in section of the device100 for reversing flow.

In itself, the device 100 for reversing flow is part of the prior art.The device according to the present invention for reversing flow differsfrom the known device in that the device according to the presentinvention has a communications arrangement which will be described indetail below. FIGS. 1 and 2 show the known device for reversing flow,with the communications arrangement not being shown.

The construction and operation of the known device for reversing flow(FIGS. 1 and 2) are described in detail in PCT Publication No. WO2006/042016 A2, the disclosure of which is hereby explicitlyincorporated by reference in its entirety. Because the device forreversing flow has already been described in detail in PCT PublicationNo. WO 2006/042016 A2, it will only be the components which are materialto the present invention which will be explained below. The device forreversing flow is connected into the extra-corporeal blood circuit I ofthe blood treating apparatus 200. FIGS. 3A and 3B show the device 100for reversing flow when connected into the extra-corporeal blood circuitI.

The first valve-action body 104 of the device for reversing flow has afirst patient-side connection 110 and a second patient-side connection112, the first patient-side connection 110 having connected to it afirst portion 110A, which is formed by flexible tubing, of the bloodline 110A, 112A, which first portion 110A is connected to the patient,and the second patient-side connection 112 having connected to it asecond portion 112A, which is formed by flexible tubing, of the bloodline 110A, 112A, which second portion 112A is connected to the patient.The second valve-action body 102 has a first apparatus-side connection106 and a second apparatus-side connection 108, the first apparatus-sideconnection 106 having connected to it a first portion 106A, formed byflexible tubing, of the blood line, which first portion 106A isconnected to the outlet 204A of the blood treating unit 204, and inparticular of the dialyzer, of the extra-corporeal blood treatingapparatus 200, and the second apparatus-side connection 108 havingconnected to it a second portion 108A, which is formed by flexibletubing, of the blood line, which second portion 108A is connected to theinlet 204B of the blood treating unit 204. As well as the blood treatingunit 204, the blood treating apparatus 200 also has a pump 202 which isconnected into that portion 108A, formed by flexible tubing, of theblood line which runs to the inlet 204B of the blood treating unit 204.FIG. 3A shows the extra-corporeal blood circuit I of the blood treatingapparatus 200 when the blood flow is not reversed, whereas FIG. 3B showsthe blood treating apparatus having the device for reversing flow whenthe blood flow is reversed.

The second valve-action body 102 is in the form of a cap-like body,whereas the first valve-action body 104 is in the form of an insertedpart. The first valve-action body 104 is seated in the secondvalve-action body 102, with the two valve-action bodies 102, 104 beingable to be rotated relative to one another between a first position anda second position on a central axis 114. Provided at the ends of theportions of the blood line which are formed by flexible tubing arematching connecting members 106B, 108B, 110B, 112B by which the portionsof flexible tubing can easily be connected to the matched, correspondingconnecting members 106, 108, 110, 112 on the device 100 for reversingflow, and detached again therefrom.

FIG. 3A shows the first position, in which a connection for liquid ismade between the first apparatus-side connection 106 and the firstpatient-side connection 110, and a connection for liquid is made betweenthe second apparatus-side connection 108 and the second patient-sideconnection 112. When the first valve-action body 104 is turned through180° relative to the second valve-action body 102 (FIG. 3B), aconnection for liquid is made between the first apparatus-sideconnection 106 and the second patient-side connection 112 and aconnection for liquid is made between the second apparatus-sideconnection 108 and the first patient-side connection 110, which meansthat the direction of flow in the extra-corporeal blood circuit I isreversed.

For the user, it is thus possible to preset the direction of flow in theblood circuit by turning the two valve-action bodies 102, 104. Thedevice 100 for reversing flow preferably makes provision for the twovalves bodies 102, 104 to be locked by latching in the first and secondpositions.

FIGS. 4A and 4B are exploded views showing a first embodiment of device100 according to the present invention for reversing flow which has acommunications arrangement 210 which communicates with the readingarrangement 270 of the blood treating apparatus 200. The readingarrangement 270, which is connected to the central control unit of thedialysis apparatus by a data line 215, generates a high-frequencyelectromagnetic field in the region close to the blood treatingapparatus 200 and the communications arrangement 210 of the device 100for reversing flow receives this field. The communications arrangement210 and the reading arrangement 270 together form an RFID system foridentifying the direction of flow in the extra-corporeal blood circuitI.

The communications arrangement 210 has a first RFID transponder 211 anda second RFID transponder 212, which are only shown in schematic form inthe drawings. The two transponders 211, 212 have an aerial (not shown)and a transceiver (not shown) and a non-erasable memory and othercircuits. Because the construction and operation of an RFID transponderare known to the person skilled in the art, there is no need for anydetailed description.

The two RFID transponders 211, 212, which are of a very small overallsize, are arranged opposite one another on the inside face of the firstvalve-action body 104. They lie on an axis which extends perpendicularlyto the axis 114 on which the two valve-action bodies 102, 104 can beturned. The axis on which the transponders lie extends perpendicularlyto the axis which extends through the two apparatus-side connections106, 108. The transponders 211, 212 are thus arranged in positionsoffset at 90° from these connections 106, 108.

The RFID transponders 211, 212 which are arranged in the firstvalve-action body 104 are screened off electrically by the secondvalve-action body 102 provided the two valve-action bodies 102, 104 arenot in one of their two positions. For the electrical screening-off, thesecond valve-action body 102 is metallized on the inside face facingtowards the first valve-action body 104. However, the metallizing forelectrical screening-off does not extend over the whole of the insideface. Instead, a sector 213 in the form of a sector of a circle is leftfree of metallizing. This sector in the form of a sector of a circle isarranged in a position offset at 90° from the apparatus-side connections106, 108 of the second valve-action body 102 and lies on the circularpath along which the two transponders 211, 212 on the secondvalve-action body 104 move when the two valve-action bodies 102, 104 areturned relative to one another.

The transponders 211, 212 and the region 213 free of metallizing are soarranged that the un-screened-off region 213 is situated opposite thefirst transponder 211 in the first position, which means the firsttransponder 211 is then active but the second transponder 212 isscreened off electrically. In the second position on the other hand, thesecond transponder 212 is active whereas the first transponder 211 isscreened off electrically.

For screening-off, metallizing may also be provided on the outside faceor on both faces. Rather than being metallized on its surface, thevalve-action body may also itself be composed of a material which is notpermeable to the high-frequency electromagnetic field from the readingarrangement. For better electrical screening-off, the secondvalve-action body also is preferably metallized on the inside face. Thismetallizing may however preferably extend over the whole of the insideface of the second valve-action body.

The two transponders are preferably passive transponders which obtaintheir energy from the high-frequency electrical field from the readingarrangement 270. When the two valve-action bodies are in the firstposition, the reading arrangement 270 reads from the first RFIDtransponder 211 a code characteristic of the first position, whereas thereading arrangement 270 reads a code characteristic of the secondposition from the second transponder 212 when the two valve-actionbodies are in the second position. The first code is, for example, acode which is made up of a serial number belonging to the RFIDtransponder and an identifier “1”, whereas the second code is a codewhich is made up of the serial number of the second transponder and anidentifier “2”. The two transponders preferably have a common serialnumber so that the transponders 211, 212 can be distinguished fromtransponders belonging to other devices for reversing flow which maylikewise be situated in the near field of the reading arrangement.

The reading of the code characteristic of the direction of flow in theextra-corporeal blood circuit can be performed continuously or at givenintervals during the blood treatment by the reading arrangement.

FIGS. 5A and 5B show a second embodiment of a device according to thepresent invention for reversing flow which differs from the firstembodiment in that the activation or de-activation, as the case may be,of the two RFID transponders is accomplished not by electricalscreening-off but by connecting the transceiver of only one of the twotransponders to a common aerial. Parts which correspond to one anotherhave therefore been given the same reference numerals. The two RFIDtransponders 211, 212 do not have internal aerials which are part of theRFID tags as they do in the case of the first embodiment but have onecommon aerial 214 which at any given time is placed in connection withthe transceiver (not shown) of one or other of the transponders 211,212. The external aerial 214 is a spiral printed-circuit-type conductorwhich is arranged on the inside face of the second valve-action body 102which faces towards the first valve-action body 104. In this embodiment,the valve-action bodies 102, 104 do not screen off the transponders 211,212 electrically.

The two RFID transponders 211, 212 have respective pairs of connections211A, 211B and 212A, 212B for the aerial. The respective firstconnections 211A, 212A of the two transponders 211, 212 are connectedvia respective connecting lines 211C, 212C to a central hollowcylindrical boss 140 on the first valve-action body 104 which, when thetwo valve-action bodies 102, 104 are plugged together (FIG. 2),surrounds a central projecting boss 150 on the second valve-action body102. The cylindrical boss 140 on the first valve-action body 104 and theprojecting boss 150 on the second valve-action body 102 are eachmetallized so that an electrical connection is made between the twovalve-action bodies.

The respective second connections 211B, 212B of the two transponders211, 212 are connected to respective electrical contacts 211E, 212E byrespective electrical connecting lines 211D, 212D. The two electricalcontacts 211E and 212E are arranged opposite one another on the insideface of the first valve-action body 104 which faces towards the secondvalve-action body 102. They lie on an axis which extends perpendicularlyto the axis of rotation 114. The axis on which the two contact-makingpoints lie extends at right angles to the axis on which the patient-sideconnections 110, 112 on the first valve-action body 104 lie, i.e. thecontacts are arranged to be offset at 90° from these connections.

The first connection of the common aerial 214 is electrically connectedto the projecting boss 150 on the second valve-action body 102, whichmeans that there is a permanent electrical connection made to the twofirst connections 211A, 212A of the two transponders 211, 212. Thesecond connection of the aerial 214 is electrically connected to asliding contact 214A which is arranged on the inside face of the secondvalve-action body 102 which faces towards the first valve-action body104.

When the two valve-action bodies 102, 104 are in the first position, thesliding contact 214A on the second valve-action body 102 makes contactwith the first contact 211E on the first valve-action body 104, whereasin the second position the sliding contact 214A makes contact with thesecond contact 212E on the second valve-action body 104. Consequently,in the first position it is only the transceiver of the firsttransponder 211, which transceiver is not in fact shown, which isconnected electrically to the aerial 214, whereas in the second positionit is only the second transceiver of the second transponder 212, whichsecond transceiver is not explicitly shown, which is connectedelectrically to the aerial 214.

As in the first embodiment, the reading arrangement 270 is only able toread the code of the first transponder 211 in the first position and inthe second position is only able to read the code of the secondtransponder 212. It is possible in this way for the direction of flow tobe clearly identified.

FIGS. 6A and 6B are simplified schematic views showing a furtherembodiment of a device according to the present invention for reversingflow which differs from the other two embodiments in that thecommunications arrangement has only a single RFID transponder. Partswhich correspond to one another are once again given the same referencenumerals.

In the alternative embodiment shown in FIGS. 6A and 6B, thecommunications arrangement 210 has an arrangement 216, which is onlyshown schematically, which detects the first and second positions of thevalve-action bodies 102, 104. An arrangement of this kind for detectingthe positions of the valve-action bodies 102, 104, may for example be aposition-dependent switch or resistive or capacitive angle sensors. Theonly crucial fact is that the arrangement 216 for detecting position forthe single RFID transponder 211 generates a signal which ischaracteristic of the first or second position. In this embodiment, thesingle RFID transponder has two codes for the two positions of thevalve-action bodies, which codes are read by the reading arrangement270.

The extra-corporeal blood treating apparatus may be a conventional bloodtreating apparatus, such as a dialysis apparatus for example, which, aswell as the known components, also has the reading arrangement 270according to the present invention. The automatic identification of thedirection of flow in the extra-corporeal blood circuit I is of advantageparticularly when the blood treating apparatus has an arrangement 240for determining a parameter of the blood treatment, such as clearancefor example, in a way which calls for a measurement of a characteristicvariable of the blood before and after reversal of the blood flow.Arrangements of this kind for determining parameters of the bloodtreatment are part of the prior art.

The arrangement 240 for determining a parameter of the blood treatmentis only schematically indicated in FIGS. 3A and 3B. The arrangement 240for determining the parameter of the blood treatment is connected to thecentral control unit 230 of the blood treating apparatus by a data line241. As well as controlling the individual sub-assemblies of the bloodtreating apparatus, the central control unit 230 is also responsible forcontrolling the reading arrangement 270 and the measuring arrangement240.

As well as this, the blood treating apparatus 200 also has an alarm unit250, which is connected to the control unit 230 by a data line 251, anda display unit 260, which is likewise connected to the control unit, bya data line 261.

For the making of a measurement of a characteristic variable before andafter the reversal of blood flow for the purpose of determining aparameter of the blood treatment, the operator prompting by the bloodtreating apparatus makes provision for the user to be requested toreverse the blood flow in the extra-corporeal blood circuit by turningthe two valve-action bodies 102, 104 of the device 100 manually. Thisrequest is signalled to the user by the display unit 260.

The first measurement having been made with normal blood flow, thereading arrangement 270 checks to see whether the user who is requestedto reverse the blood flow has reversed the blood flow by turning thevalve-action bodies 102, 104. If the user has not obeyed this request,the reading arrangement 270 finds this to be the case because it is notthe code for the second position of the valve-action bodies which isread but the code for the first position. The reading arrangement 270then generates a signal for an alarm, which the alarm unit 250 receivesvia the control unit 230. The alarm unit 250 then gives an audio and/orvisual alarm as a renewed request to the user to reverse the blood flow.

The second measurement having been made with the blood flow reversed,the user is again requested, on the display unit 260, to reverse theblood flow. The reading arrangement 270 then makes another check, to seewhether the blood flow is taking place in the original direction. If itis not, an alarm is again given. The reading arrangement finds that theposition is correct from the fact that it is not the code for the secondposition of the valve-action bodies 102, 104 which is read but the codefor their first position.

The routine for performing the measurement is preferably interrupted ifthe reading arrangement 270 has not read the correct direction of flow.Not only does this prevent incorrect measurements, but it also ensuresthat the extra-corporeal blood treatment is not conducted with areversed blood flow after the measurements. With the reading arrangement270, it is not only possible for the direction of flow to be detectedbut also for it to be found whether the valve-action bodies 102, 104 arein the correct latched position in which a connection for liquid is madebetween the connections. With the device for reversing flow which isknown from PCT Publication No. WO 2006/042016 A2, there could, forexample, be a risk that the valve-action bodies have not latched intoone of the two positions but have been mis-rotated relative to thislatched position. If this were the case, both the transponders 211, 212would be inactive, which the reading arrangement 270 would detectbecause the appropriate code would not be read. This would also be thecase when, although a connection for liquid had been made, the lumens ofthe connections situated opposite one another were not exactly in linewith one another, which would mean that only a narrow gap was left forthe blood to flow through. Because this might result in damage beingcaused to the blood by hemolysis, the blood treating apparatus 200according to the present invention preferably makes provision for theblood flow to be interrupted if the reading arrangement 270 fails todetect a proper alignment of the valve-action bodies 102, 104 relativeto one another in the two positions. The reliability and safety of theblood treatment and of the measurements are further increased by thismechanism.

In practice, there also arises the problem that a plurality of pieces ofblood treating apparatus are operated closely adjacent to one another.There is therefore a requirement for that the device for reversing bloodflow which is associated with the given piece of blood treatingapparatus to be identified.

In the blood treating apparatus 200 according to the present invention,automatic identification is performed by a test of the operation of thedevice 100 for reversing blood flow. One or more devices for reversingblood flow having been detected, the user is requested by the bloodtreating apparatus 200, on the display unit 260, to turn, relative toone another, the valve-action bodies 102, 104 of that device 100 forreversing blow which is associated with the given piece of bloodtreating apparatus. By this means, the two RFID transponders 211, 212are activated in succession within a preset interval of time which theuser requires to turn the valve-action bodies 102, 104. The readingarrangement 270 of the blood treating apparatus then detects theassociated device for reversing flow by virtue of the fact that a changebetween the codes characteristic of the two positions takes place withina preset interval of time. The reading arrangement has appropriate meansfor this. The common serial numbers in the two codes for the directionof flow which are read by the reading arrangement then allow theassociated device for reversing flow to be identified.

The menu-based prompting by the dialysis apparatus may also makeprovision for the measurements for determining a parameter of the bloodtreatment to be performed automatically solely as a result of theassociated device being detected without any further input by the userbeing required.

Together with the device for reversing flow, the blood treatingapparatus according to the present invention also has other advantagesand these are explained below.

As well as native fistulas and PTFE grafts, what are used precisely whenvascular conditions are difficult are twin-lumen central venouscatheters. In these, arterial and venous flexible blood tubes areconnected to two different parts of the catheter. To preventrecirculation, the two ends of the catheter which are fixed in place inthe vestibule are separated from one another in space (by about 2 cm).In a fully functional catheter, the withdrawal (arterial) of blood takesplace through the shorter of the two ends and the return (venous) takesplace through the longer end. It may occasionally happen that thedesired blood flow is not obtained in this configuration, the reasonsfor this not having been fully clarified (see Depner, “CatheterPerformance”, Seminars in Dialysis 14/6 (2001), pages 425-431). In suchcases, the connections are typically changed over at the catheter by thenursing staff, as a result of which the desired flow is often obtainedagain. In the literature, there are indications that a treatment inwhich the direction of flow is changed over takes place in up to 30% ofcases (N. Pannu et al., “Optimizing dialysis delivery in tunneleddialysis catheters”, ASAIO Journal 52/2 (2006), pages 57-162). Thechangeover results however in increased access recirculation, whichcauses a reduction in the efficiency of the dialysis.

By the use of the device according to the present invention forreversing flow in the system of flexible blood tubing, it is nowpossible on the other hand for the changeover to be performed easily andwith little risk of infection. On the other hand, automatic recording ofthe orientation of the flexible access tubes for blood in the dialysisunit is possible as a result of the automatic detection of position bymeans of the RFID reader in the dialysis unit. A record of treatments inwhich there are access problems can be kept automatically in this way.If, in addition, too low a clearance is detected when a measurement ofclearance is made, the interchange of the connections of the cathetermay, at the same time, be detected as a reason for the measurement ofthe excessively low clearance and can thus be distinguished from otherpossible reasons, e.g. clotting of the dialyzer.

The embodiments of the present invention which are shown in the drawingsare merely embodiments which are intended to show a particularlypreferred use of the present invention in the mechanical changeovervalve which is known from PCT Publication No. WO 2006/042016 A2. Themechanical changeover valve as such may however be of a design differentfrom that described in PCT Publication No. WO 2006/042016 A2.

The invention claimed is:
 1. A device for reversing blood flow, for anextra-corporeal blood treating apparatus which comprises anextra-corporeal blood circuit which has an arterial blood line outgoingfrom a patient which runs to a blood treating unit and a venous bloodline outgoing from the blood treating unit which runs to the patient,the device for reversing flow comprising: a first valve-action bodyhaving a first patient-side connection for a first patient-side portion,formed of flexible tubing, of the blood line and a second patient-sideconnection for a second patient-side portion, formed of flexible tubing,of the blood line; a second valve-action body having a firstapparatus-side connection for a first apparatus-side portion, formed offlexible tubing, of the blood line and a second apparatus-sideconnection for a second apparatus-side portion, formed of flexibletubing, of the blood line, the first and second valve-action bodiesbeing rotatable with respect to each other on an axis in such a waythat, in a first relative position between the first and secondvalve-action bodies, a connection for liquid is made between the firstpatient-side connection and the first apparatus-side connection, and aconnection for liquid is made between the second patient-side connectionand the second apparatus-side connection, and in a second relativeposition between the first and second valve bodies, connection forliquid is made between the first patient-side connection and the secondapparatus-side connection, and a connection for liquid is made betweenthe second patient-side connection and the first apparatus-sideconnection; a communications arrangement configured to receive ahigh-frequency electromagnetic field from a reading arrangementbelonging to the extra-corporeal blood treating apparatus and togenerate at least one code which is characteristic of one of the firstand second relative positions of the valve-action bodies and which isreadable by the reading arrangement, wherein the communicationsarrangement includes an RFID transponder configured to identify adirection of blood flow and to transmit a code characteristic of thefirst relative position and a code characteristic of the second relativeposition; and a detection arrangement configured to detect the first andsecond relative positions of the valve-action bodies and to co-operatewith the RFID transponder in such a way that, in the first relativeposition, the code characteristic of the first relative position isreadable by the reading arrangement and, in the second relativeposition, the code characteristic of the second position is readable bythe reading arrangement.
 2. The device according to claim 1, wherein theRFID transponder is a passive transponder.
 3. A blood treatingapparatus, comprising: the device for reversing blood flow according toclaim 1, an arterial blood line; a venous blood line; a blood treatingunit; and an RFID reader; wherein the apparatus is configured to carryout an extra-corporeal blood treatment in which, in the extra-corporealblood circuit, the blood of a patient flows via the arterial blood lineto the blood treating unit and via the venous blood line from the bloodtreating unit to the patient, the device for reversing blood flow beingconnected into the arterial and venous blood lines, the RFID readerbeing configured such that the code characteristic of the first orsecond relative position is readable from the communications arrangementof the device for reversing blood flow; and wherein the apparatusfurther comprises: an arrangement configured to determine a parameter ofthe blood treatment on the basis of a first measurement of acharacteristic variable before the reversal of blood flow and a secondmeasurement of a characteristic variable after the reversal of bloodflow; and an alarm unit configured to co-operate with the arrangementconfigured to determine a parameter of the blood treatment in such a waythat the alarm unit provides an alarm if, after the first measurement,the RFID reader has not received the code characteristic of the firstrelative position and if, after the second measurement, the RFID readerhas not received the code characteristic of the second relativeposition.
 4. A method of treating blood, comprising: connecting thedevice for reversing blood flow according to claim 1 to anextra-corporeal blood circuit, the extra-corporeal blood circuitcomprising an arterial blood line, a venous blood line, and a bloodtreating unit; connecting the arterial blood line and the venous bloodline to a patient; carrying out an extra-corporeal blood treatment inwhich, in the extra-corporeal blood circuit, the blood of a patientflows via the arterial blood line to the blood treating unit and via thevenous blood line from the blood treating unit to the patient, thedevice for reversing blood flow being connected into the arterial andvenous blood lines; turning the valve-action bodies to produce anidentification signal; and recognizing the communications arrangement ofthe device for reversing blood flow to detect a change between the codecharacteristics of the first and second relative positions within apreset interval of time.
 5. The device according to claim 1, wherein thedetection arrangement comprises a position-dependent switch.
 6. Thedevice according to claim 1, wherein the detection arrangement comprisesa resistive angle sensor.
 7. The device according to claim 1, whereinthe detection arrangement comprises a capacitive angle sensor.
 8. Asystem comprising an extra-corporeal blood treating apparatus and thedevice of claim 1, wherein the extra-corporeal blood treating apparatuscomprises an RFID reader configured to produce a high-frequencyelectromagnetic field and configured to read at least one code that ischaracteristic of one of the first and second positions of thevalve-action bodies.